Regulatory Affairs/Medical Writing

Our experienced regulatory experts support you regulatory affairs fro pharmaceuticals, medical devices and any other medical-related matters, survey and consulting from each phase of research to development and submission.

Regulatory related services:

Our experienced expert support you various regulatory related matters. They understand exactly technical and market information through Database search, literature search, and hearing from external professionals.

• Development Strategy and Regulatory Strategy Planning
• NDA Planning and consulting on clinical trials
• Consulting on New products development, licensing in and licensing out
• Setting up product concept and consulting to structure alliance
• Consulting for various matters related to generic products

Survey and others

intellim support you to conduct surveys to clinical practicians and end-users, literature search and others.

• Hearing from clinical practicians and researchers, survey for technology trend, literature search and market research
• Development of technology roadmap, patent map, and end-users survey

intellim’s unique Regulatory support services

• Consulting to respond to Regulatory Authorities and Consulting for clinical trial
• EU Regulation verification and Orphan drug related survey
• Feasibility study on Korean Quasi-drug
• US regulation for sales of Cosmetics

And others. Please feel free to contact us.